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Federalwide Assurances: What Are They; Why and When Do I Need Them?

Summary

  • Federal wide Assurance

  • Individual Investigator Agreement

  • IRB Authorization Agreement

  • When these agreements are used.

  • Why these agreements are used.

  • The process for establishing these agreements

  • Are there other types of agreements that institutions may enter into and how those would meet the regulatory framework.

Overview

The Federal wide Assurance is required for NIH funded studies. It is a written assurance filed with the Office for Human Research Protections (OHRP) that outlines under which terms a study will be reviewed, approved, and conducted. This document, signed by the Institutional Official, sets forth certain requirements that must be upheld by an institution who has filed such an agreement. One of the terms deals with written agreements for non-affiliated investigators and institutions.

When a researcher engages a site or individual not currently governed by his/her home institution, the researcher has the option of asking the non-affiliated site or individual to obtain a separate IRB approval or to request that his home institutional review board become the IRB of Record.

Who should attend?

  • Principal Investigators / Sub-investigators.
  • Clinical Research Scientists (PKs, Biostatisticians,)
  • Safety Nurses
  • Clinical Research Associates (CRAs) and Coordinators (CRCs)
  • Recruiting staff
  • QA / QC auditors and staff
  • Clinical Research Data managers
  • Human Research Protection professionals

Sarah Fowler-Dixon

Expert

Sarah Fowler-Dixon, PhD, CIP is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, and submission and reviewer forms often working with state and federal authorities. She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research management to graduate and undergraduate students.

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